Search Form
First, enter a politician or zip code
Now, choose a category

Public Statements

Food and Drug Administration Safety and Innovation Act of 2012--Continued

Floor Speech

Location: Washington, DC


Mr. LEAHY. Madam President, I am pleased that Congress will finally send to the President the bipartisan Food and Drug Administration Safety and Innovation Act, FDASIA. This legislation previously received overwhelming support in the Senate and was passed by the House of Representatives by a voice vote just last week. This final action by the Senate will reauthorize the prescription drug user fee program and medical device user fee which are set to expire on October 1, 2012. It will also authorize two new provisions to allow the FDA to review and approve generic drugs and biosimilar drugs in a timely manner. Importantly, this bill includes several provisions that I have supported to prevent access to dangerous drugs.

Passage of the FDASIA will help stop drug shortages that affect thousands of Americans. I have heard from a number of Vermonters concerned about the uncertainty of availability of lifesaving drugs and devices. While the FDASIA will not stop all drug shortages, I hope it will give Vermonters who depend on these medications relief knowing more steps are being taken to ensure these shortages don't happen.

This legislation also includes an important provision I have been proud to author to address the problem of counterfeit drugs. In March, the Senate passed by unanimous consent bipartisan legislation that I introduced with Senator Grassley to deter the sale of counterfeit drugs. The Counterfeit Drug Penalty Enhancement Act, S. 1886, has the support of groups such as the Alliance for Safe Online Pharmacies, the Easter Seals, and the U.S. Chamber of Commerce. The legislation is consistent with recommendations from the Intellectual Property Enforcement Coordinator and the administration's Counterfeit Pharmaceutical Interagency Working Group. I am pleased that a compromise version of this legislation will become law as part of S. 3187.

I am also glad that the final bill includes important provisions addressing the issue of synthetic drugs. These provisions correspond to three bills that the Senate Judiciary Committee passed last year--the Combating Dangerous Synthetic Stimulants Act, S. 409; the Combating Designer Drugs Act, S. 839; and the Dangerous Synthetic Drug Control Act, S. 605. I was glad to move these bills through the committee last year and to work to try to pass them in the full Senate. They address substances commonly known as ``bath salts'' and other synthetic drugs that have no legitimate use and can too easily be obtained under current law. Bath salts have resulted in a number of reports of individuals acting violently in the United States, including in Vermont, and have led to injuries to those using them and to others.

I thank Senators Klobuchar, Grassley, Portman, and Schumer for their leadership on this issue. I was glad to be able to work with them and with Senator Harkin to support including these important provisions in the FDA bill and keeping them there in negotiations with the House. It is good that we are able to make real progress in this area.

I am also glad that we are moving forward on this issue in a responsible way after appropriate consideration. Adding chemicals to schedule I of the Controlled Substances Act has serious consequences and is not a step that we should undertake without careful consideration. We will continue to study this issue and consult with the DEA, FDA, and others going forward.

I note also that Senator Paul has expressed serious concerns about the mandatory minimum sentences contained in the Controlled Substances Act, mandatory sentences that are expanded every time we schedule new substances. I appreciate those concerns. As more and more of our criminal justice budget goes to housing more and more people in prison for ever longer periods of time, rather than supporting prevention programs and law enforcement which can more efficiently and effectively reduce crime, we have to rethink our reliance on mandatory minimum sentences, particularly for nonviolent drug offenses. In the future, I intend to work with Senator Paul and others on this vital issue.

Finally, I am pleased that the final FDASIA includes language to protect the public's ability to access information under the Freedom of Information Act, FOIA. This bill will allow the Food and Drug Administration, FDA, to obtain important information about drug inspections and drug investigations undertaken by foreign governments, while at the same time ensuring that the American public has access to information about potential health and safety dangers. This provision carefully balances the need for the government to keep some information confidential, with the need to ensure free flow of information in our democratic society. A number of Senators, including Senator Harkin and Senator Enzi, and a number of open government and consumer groups, including and Public Citizen, worked with me to protect the public's access to FDA information in this bill.

Sending this legislation to the President's desk will save lives. The Senate's action will also mitigate the uncertainty facing the FDA should these user fees expire. I am pleased to support this legislation and urge other Senators to do so as well.


Skip to top

Help us stay free for all your Fellow Americans

Just $5 from everyone reading this would do it.

Back to top